Depressive Disorder, MajorNCT06311136
Effectiveness of an Ecological Momentary Emotion Regulation Intervention
A study testing Valence-Specific Ecological Momentary Intervention in people with Depressive Disorder, Major and Persistent Depressive Disorder, run by Heidelberg University at 1 site in Germany.
Trial summary
This two-armed randomized controlled trial aims to investigate the effectiveness of an emotion regulation intervention in individuals with and without depressive disorders. The study encompasses participants diagnosed with mild to moderate major depression or persistent depressive disorder and healthy controls without… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major, Persistent Depressive Disorder, Healthy
- What is being tested?
- Valence-Specific Ecological Momentary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 12 Jan 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Online consent for participation
- Adequate proficiency in the German language, encompassing both reading and comprehension skills
- Ownership of a smartphone, compatible with either Android or iOS operating systems, and access to the Internet
- For individuals in the clinical group with current depressive disorders:
- Currently meeting the DSM-5 criteria for a mild or moderate major depressive episode, or persistent depressive disorder
Who cannot join
- Current severe substance use disorder
- Acute suicidality
- Current severe major depressive episode
- Lifetime bipolar disorder
- Lifetime psychotic disorders
- For the control group, additional exclusion criteria include:
Show all 11Show fewer
- Meeting the DSM-5 criteria for a major depressive episode within the last 12 months
- History of severe major depressive episodes
- Recurrent depressive disorder
- History of persistent depressive disorder
- Current treatment (psychotherapy, pharmacotherapy) for depressive symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Heidelberg University
Heidelberg, 69117
Ilka Mueller, M.Sc., +496221/547362, ilka.mueller@psychologie.uni-heidelberg.de
Luise Pruessner, M.Sc., +496221/547282, luise.pruessner@psychologie.uni-heidelberg.de
About this study
Official title: Effectiveness of an Ecological Momentary Emotion Regulation Intervention Among Individuals With and Without Depressive Disorders: A Randomized-Controlled Trial
This two-armed randomized controlled trial aims to investigate the effectiveness of an emotion regulation intervention in individuals with and without depressive disorders. The study encompasses participants diagnosed with mild to moderate major depression or persistent depressive disorder and healthy controls without a current depressive disorder.
Participants will be randomly assigned to either the intervention group, receiving a valence-specific emotion regulation intervention in daily life, or a monitoring-only control group. The valence-specific intervention supports the implementation of different emotion regulation strategies based on whether a person is experiencing mainly positive or negative emotions. In contrast, participants in the control group will solely monitor their positive and negative emotions and the strategies used to regulate them.
Read more
Outcome measures include emotion regulation ability, self-efficacy, and strategy use, depressive symptoms, positive and negative affect, and emotion beliefs (controllability, usefulness).
A second aim of the study is to compare beliefs about positive emotions and strategies to regulate them between individuals with and without current depressive disorders. Furthermore, the investigators aim to examine why individuals might choose unfavorable emotion regulation strategies even when feeling good. Therefore, another research question is, how emotion beliefs might explain emotion regulation strategy choice.
Read the detailed description
Background:
Affective disorders, such as depression, have been consistently associated with deficiencies not only in the regulation of negative emotions but also in the maintenance and upregulation of positive emotions. However, the mechanisms underlying emotion regulation deficits in depressive disorders remain inadequately understood. Recently, there has been a growing interest in the role of beliefs about emotions as factors contributing to emotion regulation deficits in psychopathology. In light of this, this study seeks to explore potential differences in beliefs about positive (and negative) emotions between individuals with and without current depressive disorders. Another aim of this study is to examine how these individual differences in emotion beliefs predict the selection of emotion regulation strategies in daily life, particularly in the context of positive emotions.
Given the pivotal role that deficits in emotion regulation play in the onset and persistence of depressive disorders, this study aims to investigate whether an ecological momentary intervention, addressing both positive and negative emotion regulation, can effectively improve emotion regulation processes. Recent research suggests that distinct emotion regulation strategies may be effective for positive versus negative emotion regulation. Consequently, this study aims to evaluate the effectiveness of a smartphone-based, valence-specific emotion regulation intervention in individuals with and without current depressive disorders.
Method:
This study will enlist participants aged between 18 and 65, diagnosed with mild to moderate major depression or persistent depressive disorder, as well as healthy controls without a current depressive disorder. Individuals presenting with a current severe substance use disorder, acute suicidality, an ongoing severe major depressive episode, a history of bipolar disorder, or lifetime psychotic disorders are precluded from participation in both groups. Additional exclusion criteria for participation within the control cohort encompass (a) occurrence of a major depressive episode in the preceding 12 months, (b) history of severe major depressive episodes, (c) diagnosis of recurrent depressive disorder or history of persistent depressive disorder, and (d) ongoing treatment modalities related to a depressive episode, including psychotherapy or pharmacotherapy.
Participants will undergo baseline questionnaires before completing four daily smartphone-based assessments over seven consecutive days, evaluating their emotion beliefs, emotion regulation, and emotional outcomes. Participants will be randomly assigned to either the intervention or the monitoring-only control group. Following a four-day break, participants in the intervention group will receive a valence-specific ecological momentary intervention targeting emotion regulation in daily life. During this period, participants will report their emotional experiences twice daily and will be supported in implementing either reappraisal or savoring strategies based on the valence of their current predominant emotion. Participants in the control group will be instructed to complete two daily assessments, monitoring their emotions and the strategies used to regulate them. After an additional four-day break, participants will be invited to complete post-assessment questionnaires capturing emotion regulation ability, self-efficacy and strategy use, depressive symptoms, emotion beliefs (controllability, usefulness), and another week of ecological momentary assessment (four per day), encompassing, among other variables, the use of emotion regulation strategies and the experience of positive and negative emotions.
Hypotheses:
The valence-specific intervention is hypothesized to enhance emotion regulation ability and self-efficacy, emotional outcomes (depressive symptoms, positive and negative affect), and emotion beliefs (controllability, usefulness) and to increase the application of reappraisal in negative and savoring in positive emotional contexts in daily life.
The investigators hypothesize that individuals with current depressive disorders will report more unfavorable beliefs about emotions and higher use of strategies associated with dampening positive emotions compared to controls at baseline.
Furthermore, the investigators expect that unfavorable beliefs about positive emotions at baseline (i.e., assuming that positive emotions are harmful) may predict the selection of dampening strategies in the context of positive emotions.
- Being tested
- Valence-Specific Ecological Momentary Intervention
- Keywords
- Emotion Beliefs, Emotional Regulation, Positive Emotions, Affective Symptoms, Ecological Momentary Assessment, Internet-Based Intervention, Depression
- Medical subject headings
- Depressive Disorder, Major, Emotional Regulation, Affective Symptoms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valence-Specific Ecological Momentary InterventionBehavioural
The ecological momentary intervention is designed to enhance participants ability to select and effectively implement emotion regulation strategies fitting to the valence of their current emotions. Specifically, the intervention instructs participants to use the strategy of savoring to amplify their positive emotions, fostering an appreciation for the present moment. Conversely, for the attenuation of negative emotions, the intervention advocates to use the strategy of reappraisal, encouraging participants to reinterpret adverse situations in a more positive or neutral way, thus reducing their emotional impact. This targeted approach ensures that the emotion regulation strategies are not only effective but also contextually appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants complete a valence-specific ecological momentary intervention twice daily over 14 consecutive days.
The ecological momentary intervention is presented as the "Positive Everyday Affect Knowledge" (PEAK) diary and includes valence-specific emotion regulation strategy instructions. Participants receive reminders to complete surveys on their strongest emotions since the last assessment. Depending on the valence of this emotion, they receive instructions on how to use the strategy savoring (for positive emotions) or reappraisal (for negative emotions). Receives: Behavioral: Valence-Specific Ecological Momentary Intervention |
| Monitoring-only control group | No intervention | Participants complete a valence-specific ecological momentary assessment twice daily over 14 consecutive days. The ecological momentary assessment is presented as the "Positive Everyday Affect Knowledge" (PEAK) diary, and only involves monitoring participants' emotional experiences and regulation. Participants receive reminders to complete surveys on their strongest emotions since the last assessment. Depending on the valence of this emotion (positive versus negative), they are asked about their emotion regulation strategies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Regulation Ability (Positive, Negative Emotions)
The Perth Emotion Regulation Competency Inventory (PERCI; Preece al., 2021) consists of 32 items, rated on a 7-point scale (1 = strongly disagree, 4 = neither agree nor disagree, 7 = strongly agree) and measures people's ability to regulate their positive and negative emotions. Two different composite scores can be computed to indicate positive and negative emotion regulation ability (Min = 16, Max = 112 for each score), with higher scores indicating a higher level of difficulty regulating positive or negative emotions.
Measured: 0 weeks, 3 weeks
Emotion Regulation Self-Efficacy for Positive and Negative Emotions
The German version of the Regulatory Emotional Self-Efficacy-Revised (RESE-R) Scale (adapted from Caprara et al., 2008) consists of 10 items, rated on a 5-point scale (1 = not at all well to 5 = very well). The scale assesses self-efficacy in expressing positive emotions (4 items, Min = 1, Max = 5) and in managing negative emotions (despondency/distress: 3 Items, anger/irritation: 3 items, Min = 1, Max = 5), with higher scores indicating higher self-efficacy beliefs.
Measured: 0 weeks, 3 weeks
Secondary outcomes (4)
Emotion Regulation Strategy Use in Positive and Negative Emotional Contexts
Data will be collected using an adaption of the smartphone app EmoTrack (adapted from Pruessner et al., 2023). The app assesses among other factors, the intensity with which participants employ various emotion regulation strategies to manage specific positive and negative emotions, using an 11-point scale (1 = not at all, 11 = very much). Scores for strategy usage will be aggregated across all intensity ratings from the four daily measurements over a continuous seven-day period (Min = 1, Max = 11). Higher scores indicate that a participant engages in a specific strategy more strongly in daily life.
Measured: 0 weeks, 3 weeks
Depressive Symptoms
The Beck Depression Inventory-II (Wang et al., 2013) consists of 21 items, rated on a 4-point scale (0-3) with four statements of increasing severity related to a specific depressive symptom. Higher sum scores (Min = 0, Max = 63) indicate a higher severity of depressive symptoms.
Measured: 0 weeks, 3 weeks
Positive and Negative Affect
Data will be collected using an adaption of the smartphone app EmoTrack (adapted from Pruessner et al., 2023). The app measures among other factors, the intensity of specific positive and negative emotions selected from the Positive and Negative Affect Schedule - Expanded Form (PANAS-X; Watson \& Clark, 1994), using an 11-point scale (1 = not at all, 11 = very much). Scores for positive and negative emotions will be aggregated across all intensity ratings from the four daily measurements over a continuous seven-day period (Min = 1, Max = 11). Higher scores indicate that participants experience a higher level of positive (resp. negative) emotions in daily life.
Measured: 0 weeks, 3 weeks
Emotion Beliefs (Controllability, Usefulness) about Positive and Negative Emotions
The Emotion Beliefs Questionnaire (EBQ, Becerra et al., 2020) consists of 16 items, rated on a 7-point scale (1 = strongly disagree, 4 = neither agree nor disagree, 7 = strongly agree). Sum scores can be computed for different subscales: General-Contollability (8 Items, Min: 8; Max: 56), Positive-Usefulness (4 Items, Min: 4, Max: 28), Negative-Usefulness (4 Items, Min: 4, Max: 28), with higher scores indicating that people believe, that emotions are uncontrollable and useless.
Measured: 0 weeks, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start12 Jan 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with an Intervention Group and a Control Group without an intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilka Mueller, Heidelberg University
- Investigators
- Ilka Mueller, M.Sc., Principal investigator, Department of Psychology, Heidelberg UniversityLuise Pruessner, M.Sc., Principal investigator, Department of Psychology, Heidelberg UniversitySteffen Hartmann, M.Sc., Principal investigator, Department of Psychology, Heidelberg UniversitySven Barnow, PhD, Study chair, Department of Psychology, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311136
- Sponsor's protocol ID
- PEAK
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified dataset
Publications
Park LE, Fujita K, Naragon-Gainey K, Radsvick TM, Jung HY, Xia J, Ward DE, Paravati E, Weng J, Italiano A, Valvo A. Happiness-To enjoy now or later? Consequences of delaying happiness and living in the moment beliefs. Emotion. 2023 Feb;23(1):138-162. doi: 10.1037/emo0000850. Epub 2021 Nov 15.
PubMed 34780240Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.
PubMed 28730850Llera SJ, Newman MG. Development and validation of two measures of emotional contrast avoidance: The contrast avoidance questionnaires. J Anxiety Disord. 2017 Jun;49:114-127. doi: 10.1016/j.janxdis.2017.04.008. Epub 2017 Apr 28.
PubMed 28500921Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962Roth M, Altmann T. A Comparison of the Predictive Validity of Self-Esteem Level and Directly Measured Self-Esteem Stability in the Temporal Prediction of Psychological Distress. Front Psychol. 2020 Jul 24;11:1770. doi: 10.3389/fpsyg.2020.01770. eCollection 2020.
PubMed 32849049Becerra R, Preece DA, Gross JJ. Assessing beliefs about emotions: Development and validation of the Emotion Beliefs Questionnaire. PLoS One. 2020 Apr 14;15(4):e0231395. doi: 10.1371/journal.pone.0231395. eCollection 2020.
PubMed 32287328Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 16367493Joshanloo M, Lepshokova ZK, Panyusheva T, Natalia A, Poon WC, Yeung, VWL, ... & Jiang DY. Cross-cultural validation of Fear of Happiness Scale across 14 national groups. Journal of Cross-Cultural Psychology. 2014; 45(2): 246-264.
Preece DA, Becerra R, Sauer-Zavala S, Boyes M, McEvoy P, Villanueva C, Ibonie S, Gruber J, Hasking P, Gross JJ. Assessing Emotion Regulation Ability for Negative and Positive Emotions: Psychometrics of the Perth Emotion Regulation Competency Inventory in United States Adults. J Affect Disord. 2021 Nov 1;294:558-567. doi: 10.1016/j.jad.2021.07.055. Epub 2021 Jul 16.
PubMed 34330052Caprara GV, Di Giunta L, Eisenberg N, Gerbino M, Pastorelli C, Tramontano C. Assessing regulatory emotional self-efficacy in three countries. Psychol Assess. 2008 Sep;20(3):227-37. doi: 10.1037/1040-3590.20.3.227.
PubMed 18778159Watson D, Clark LA. The PANAS-X: Manual for the Positive and Negative Affect Schedule - Expanded Form [Unpublished Manuscript] University of Iowa. 1994.
Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
PubMed 24402217Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Niessen D, Schmidt I, Groskurth K, Rammstedt B, Lechner CM. The Internal-External Locus of Control Short Scale-4 (IE-4): A comprehensive validation of the English-language adaptation. PLoS One. 2022 Jul 11;17(7):e0271289. doi: 10.1371/journal.pone.0271289. eCollection 2022.
PubMed 35816496
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Ecological Momentary Emotion Regulation Intervention Among Individuals With and Without Depressive Disorders: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT06311136
- Acronym / sponsor ID
- PEAK
- Keywords
- Emotion Beliefs, Emotional Regulation, Positive Emotions, Affective Symptoms, Ecological Momentary Assessment, Internet-Based Intervention, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This two-armed randomized controlled trial aims to investigate the effectiveness of an emotion regulation intervention in individuals with and without depressive disorders. The study encompasses participants diagnosed with mild to moderate major depression or persistent depressive disorder and healthy controls without a current depressive disorder.
Participants will be randomly assigned to either the intervention group, receiving a valence-specific emotion regulation intervention in daily life, or a monitoring-only control group. The valence-specific intervention supports the implementation of different emotion regulation strategies based on whether a person is experiencing mainly positive or negative emotions. In contrast, participants in the control group will solely monitor their positive and negative emotions and the strategies used to regulate them.
Outcome measures include emotion regulation ability, self-efficacy, and strategy use, depressive symptoms, positive and negative affect, and emotion beliefs (controllability, usefulness).
A second aim of the study is to compare beliefs about positive emotions and strategies to regulate them between individuals with and without current depressive disorders. Furthermore, the investigators aim to examine why individuals might choose unfavorable emotion regulation strategies even when feeling good. Therefore, another research question is, how emotion beliefs might explain emotion regulation strategy choice.
Detailed description
Background:
Affective disorders, such as depression, have been consistently associated with deficiencies not only in the regulation of negative emotions but also in the maintenance and upregulation of positive emotions. However, the mechanisms underlying emotion regulation deficits in depressive disorders remain inadequately understood. Recently, there has been a growing interest in the role of beliefs about emotions as factors contributing to emotion regulation deficits in psychopathology. In light of this, this study seeks to explore potential differences in beliefs about positive (and negative) emotions between individuals with and without current depressive disorders. Another aim of this study is to examine how these individual differences in emotion beliefs predict the selection of emotion regulation strategies in daily life, particularly in the context of positive emotions.
Given the pivotal role that deficits in emotion regulation play in the onset and persistence of depressive disorders, this study aims to investigate whether an ecological momentary intervention, addressing both positive and negative emotion regulation, can effectively improve emotion regulation processes. Recent research suggests that distinct emotion regulation strategies may be effective for positive versus negative emotion regulation. Consequently, this study aims to evaluate the effectiveness of a smartphone-based, valence-specific emotion regulation intervention in individuals with and without current depressive disorders.
Method:
This study will enlist participants aged between 18 and 65, diagnosed with mild to moderate major depression or persistent depressive disorder, as well as healthy controls without a current depressive disorder. Individuals presenting with a current severe substance use disorder, acute suicidality, an ongoing severe major depressive episode, a history of bipolar disorder, or lifetime psychotic disorders are precluded from participation in both groups. Additional exclusion criteria for participation within the control cohort encompass (a) occurrence of a major depressive episode in the preceding 12 months, (b) history of severe major depressive episodes, (c) diagnosis of recurrent depressive disorder or history of persistent depressive disorder, and (d) ongoing treatment modalities related to a depressive episode, including psychotherapy or pharmacotherapy.
Participants will undergo baseline questionnaires before completing four daily smartphone-based assessments over seven consecutive days, evaluating their emotion beliefs, emotion regulation, and emotional outcomes. Participants will be randomly assigned to either the intervention or the monitoring-only control group. Following a four-day break, participants in the intervention group will receive a valence-specific ecological momentary intervention targeting emotion regulation in daily life. During this period, participants will report their emotional experiences twice daily and will be supported in implementing either reappraisal or savoring strategies based on the valence of their current predominant emotion. Participants in the control group will be instructed to complete two daily assessments, monitoring their emotions and the strategies used to regulate them. After an additional four-day break, participants will be invited to complete post-assessment questionnaires capturing emotion regulation ability, self-efficacy and strategy use, depressive symptoms, emotion beliefs (controllability, usefulness), and another week of ecological momentary assessment (four per day), encompassing, among other variables, the use of emotion regulation strategies and the experience of positive and negative emotions.
Hypotheses:
The valence-specific intervention is hypothesized to enhance emotion regulation ability and self-efficacy, emotional outcomes (depressive symptoms, positive and negative affect), and emotion beliefs (controllability, usefulness) and to increase the application of reappraisal in negative and savoring in positive emotional contexts in daily life.
The investigators hypothesize that individuals with current depressive disorders will report more unfavorable beliefs about emotions and higher use of strategies associated with dampening positive emotions compared to controls at baseline.
Furthermore, the investigators expect that unfavorable beliefs about positive emotions at baseline (i.e., assuming that positive emotions are harmful) may predict the selection of dampening strategies in the context of positive emotions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with an Intervention Group and a Control Group without an intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Valence-Specific Ecological Momentary InterventionParticipants complete a valence-specific ecological momentary intervention twice daily over 14 consecutive days. The ecological momentary intervention is presented as the "Positive Everyday Affect Knowledge" (PEAK) diary and includes valence-specific emotion regulation strategy instructions. Participants receive reminders to complete surveys on their strongest emotions since the last assessment. Depending on the valence of this emotion, they receive instructions on how to use the strategy savoring (for positive emotions) or reappraisal (for negative emotions). |
| Monitoring-only control group | No intervention | –Participants complete a valence-specific ecological momentary assessment twice daily over 14 consecutive days. The ecological momentary assessment is presented as the "Positive Everyday Affect Knowledge" (PEAK) diary, and only involves monitoring participants' emotional experiences and regulation. Participants receive reminders to complete surveys on their strongest emotions since the last assessment. Depending on the valence of this emotion (positive versus negative), they are asked about their emotion regulation strategies. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Online consent for participation
- Adequate proficiency in the German language, encompassing both reading and comprehension skills
- Ownership of a smartphone, compatible with either Android or iOS operating systems, and access to the Internet
- Currently meeting the DSM-5 criteria for a mild or moderate major depressive episode, or persistent depressive disorder
Key exclusion criteria (11 listed)
- Current severe substance use disorder
- Acute suicidality
- Current severe major depressive episode
- Lifetime bipolar disorder
- Lifetime psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valence-Specific Ecological Momentary InterventionThe ecological momentary intervention is designed to enhance participants ability to select and effectively implement emotion regulation strategies fitting to the valence of their current emotions. Specifically, the intervention instructs participants to use the strategy of savoring to amplify their positive emotions, fostering an appreciation for the present moment. Conversely, for the attenuation of negative emotions, the intervention advocates to use the strategy of reappraisal, encouraging participants to reinterpret adverse situations in a more positive or neutral way, thus reducing their emotional impact. This targeted approach ensures that the emotion regulation strategies are not only effective but also contextually appropriate. | Behavioural | Intervention group |
Primary outcome
Emotion Regulation Ability (Positive, Negative Emotions)
Time frame: 0 weeks, 3 weeks
The Perth Emotion Regulation Competency Inventory (PERCI; Preece al., 2021) consists of 32 items, rated on a 7-point scale (1 = strongly disagree, 4 = neither agree nor disagree, 7 = strongly agree) and measures people's ability to regulate their positive and negative emotions. Two different composite scores can be computed to indicate positive and negative emotion regulation ability (Min = 16, Max = 112 for each score), with higher scores indicating a higher level of difficulty regulating positive or negative emotions.
Emotion Regulation Self-Efficacy for Positive and Negative Emotions
Time frame: 0 weeks, 3 weeks
The German version of the Regulatory Emotional Self-Efficacy-Revised (RESE-R) Scale (adapted from Caprara et al., 2008) consists of 10 items, rated on a 5-point scale (1 = not at all well to 5 = very well). The scale assesses self-efficacy in expressing positive emotions (4 items, Min = 1, Max = 5) and in managing negative emotions (despondency/distress: 3 Items, anger/irritation: 3 items, Min = 1, Max = 5), with higher scores indicating higher self-efficacy beliefs.
4 secondary outcomes
Emotion Regulation Strategy Use in Positive and Negative Emotional Contexts
Time frame: 0 weeks, 3 weeks
Depressive Symptoms
Time frame: 0 weeks, 3 weeks
Positive and Negative Affect
Time frame: 0 weeks, 3 weeks
Emotion Beliefs (Controllability, Usefulness) about Positive and Negative Emotions
Time frame: 0 weeks, 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Background: PubMed 34780240Park LE, Fujita K, Naragon-Gainey K, Radsvick TM, Jung HY, Xia J, Ward DE, Paravati E, Weng J, Italiano A, Valvo A. Happiness-To enjoy now or later? Consequences of delaying happiness and living in the moment beliefs. Emotion. 2023 Feb;23(1):138-162. doi: 10.1037/emo0000850. Epub 2021 Nov 15.
- Background: PubMed 28730850Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.
- Background: PubMed 28500921Llera SJ, Newman MG. Development and validation of two measures of emotional contrast avoidance: The contrast avoidance questionnaires. J Anxiety Disord. 2017 Jun;49:114-127. doi: 10.1016/j.janxdis.2017.04.008. Epub 2017 Apr 28.
- Background: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Background: PubMed 32849049Roth M, Altmann T. A Comparison of the Predictive Validity of Self-Esteem Level and Directly Measured Self-Esteem Stability in the Temporal Prediction of Psychological Distress. Front Psychol. 2020 Jul 24;11:1770. doi: 10.3389/fpsyg.2020.01770. eCollection 2020.
- Background: PubMed 32287328Becerra R, Preece DA, Gross JJ. Assessing beliefs about emotions: Development and validation of the Emotion Beliefs Questionnaire. PLoS One. 2020 Apr 14;15(4):e0231395. doi: 10.1371/journal.pone.0231395. eCollection 2020.
- Background: PubMed 16367493Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- BackgroundJoshanloo M, Lepshokova ZK, Panyusheva T, Natalia A, Poon WC, Yeung, VWL, ... & Jiang DY. Cross-cultural validation of Fear of Happiness Scale across 14 national groups. Journal of Cross-Cultural Psychology. 2014; 45(2): 246-264.
- Background: PubMed 34330052Preece DA, Becerra R, Sauer-Zavala S, Boyes M, McEvoy P, Villanueva C, Ibonie S, Gruber J, Hasking P, Gross JJ. Assessing Emotion Regulation Ability for Negative and Positive Emotions: Psychometrics of the Perth Emotion Regulation Competency Inventory in United States Adults. J Affect Disord. 2021 Nov 1;294:558-567. doi: 10.1016/j.jad.2021.07.055. Epub 2021 Jul 16.
- Background: PubMed 18778159Caprara GV, Di Giunta L, Eisenberg N, Gerbino M, Pastorelli C, Tramontano C. Assessing regulatory emotional self-efficacy in three countries. Psychol Assess. 2008 Sep;20(3):227-37. doi: 10.1037/1040-3590.20.3.227.
- BackgroundWatson D, Clark LA. The PANAS-X: Manual for the Positive and Negative Affect Schedule - Expanded Form [Unpublished Manuscript] University of Iowa. 1994.
- Background: PubMed 24402217Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
- Individual participant dataSharing planned: Yes. De-identified dataset
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilka Mueller, M.Sc. principal investigator
Department of Psychology, Heidelberg University
Luise Pruessner, M.Sc. principal investigator
Department of Psychology, Heidelberg University
Steffen Hartmann, M.Sc. principal investigator
Department of Psychology, Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valence-Specific Ecological Momentary Intervention in people with Depressive Disorder, Major and Persistent Depressive Disorder, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilka Mueller, M.Sc. (+496221/547362, ilka.mueller@psychologie.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Ability (Positive, Negative Emotions) (time frame: 0 weeks, 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06311136, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.